Condition: Rheumatoid Arthritis (RA) · Sponsor: taVNS AB
Purpose and aim The overall aim is to investigate efficacy and safety of a newly developed non-invasive auricular investigational device that electrically stimulates the auricular branch of the vagus nerve to activate the cholinergic anti-inflammatory mechanism to treat rheumatoid arthritis patients not responding to standard therapy. The mode of treatment is termed transcutaneous auricular vagus nerve stimulation (taVNS). Specifically, the investigators will address the following research questions: The investigation is a multicenter, placebo-controlled, randomized, double-blinded, superiority, clinical study to evaluate the safety and efficacy of a novel transcutaneous auricular vagus nerve stimulator system, termed TRAVAGUS, in patients with moderate-to-severe rheu-matoid arthritis (RA) who are incomplete responders or are intolerant to biologic or targeted synthetic disease modifying anti-rheumatic drugs (DMARDs). The primary efficacy endpoint is the proportion of patients achieving an ACR20 response (a composite measure of the effectiveness of arthritis treatments set forth by the American College of Rheumatology) in the treatment group compared to sham group at 12 weeks. Electrical vagus nerve stimulation is an investigational anti-inflammatory therapy targeting the nervous system to modulate immune activity. RA is a global disease associated with significant reduced quality of life and very high health care costs substantially driven by therapeutics. While many with …
This description comes directly from the study's public registry record.
Jon Lampa, Professor · +46 12370000 · jon.lampa@ki.se
Linda Regner-Dyberg, Secretary · +46812370000 · linda.regner-dyberg@regionstockholm.se
Always discuss trial participation with your own doctor first.
| Section for Rheumatology, Skåne University Hospital, Lund | Lund, Skåne County, Sweden | Recruiting |
| Section for Rheumatology, Skåne University Hospital, Malmö | Malmö, Sweden | Recruiting |
| Dept of Rheumatology, Örebro University Hospital | Örebro, Sweden | Recruiting |
| Center for Rheumatology, Academic Specialist Centre | Stockholm, Sweden | Recruiting |
| Karolinska University Hospital | Stockholm, Sweden | Recruiting |
| Dept of Rheumatology, Umeå University Hospital | Umeå, Sweden | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06779123